Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 2:03 AM
Study NCT ID:
NCT06251934
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2024-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients With BRAF-Positive Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 785}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean age of 1L dab/tram-treated BRAF+ MM patients', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L dab/tram-treated BRAF+ MM patients who identify per sex', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L dab/tram-treated BRAF+ MM patients per race category', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L dab/tram-treated BRAF+ MM patients per ethnicity category', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L dab/tram-treated BRAF+ MM patients per geographic region', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L dab/tram-treated BRAF+ MM patients per type of medical practice', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L dab/tram-treated BRAF+ MM patients per insurance type', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L dab/tram-treated BRAF+ MM patients with an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, 2, 3, or 4', 'timeFrame': 'Baseline', 'description': "ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead)."}, {'measure': 'Number and percentage of 1L dab/tram-treated BRAF+ MM patients per location of metastatic site', 'timeFrame': 'Baseline'}, {'measure': 'Alanine aminotransferase (ALT) levels in 1L dab/tram-treated BRAF+ MM patients', 'timeFrame': 'Baseline'}, {'measure': 'Aspartate aminotransferase (AST) levels in 1L dab/tram-treated BRAF+ MM patients', 'timeFrame': 'Baseline'}, {'measure': 'Lactate dehydrogenase (LDH) levels in 1L dab/tram-treated BRAF+ MM patients', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L dab/tram-treated BRAF+ MM patients treated with 2L therapy', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Time from the start of 1L dab/tram therapy until the start of 2L therapy', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Real-world progression-free survival (rwPFS) for 1L dab/tram-treated BRAF+ MM patients', 'timeFrame': 'Up to approximately 2 years', 'description': 'rwPFS was defined as the time from the start of 1L dab/tram therapy until first progression or death from any cause.'}, {'measure': 'Overall survival (OS) for 1L dab/tram-treated BRAF+ MM patients', 'timeFrame': 'Up to approximately 2 years', 'description': 'OS was defined as the time from the start of 1L dab/tram therapy until death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Mean age of 1L IO-refractory patients with BRAF+ MM', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L IO-refractory patients with BRAF+ MM who identify per sex', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L IO-refractory patients with BRAF+ MM per race category', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L IO-refractory patients with BRAF+ MM per ethnicity category', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L IO-refractory patients with BRAF+ MM per geographic region', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L IO-refractory patients with BRAF+ MM per type of medical practice', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L IO-refractory patients with BRAF+ MM per insurance type', 'timeFrame': 'Baseline'}, {'measure': 'Number and percentage of 1L IO-refractory patients with BRAF+ MM with an ECOG score of 0, 1, 2, 3, or 4', 'timeFrame': 'Baseline', 'description': "ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead)."}, {'measure': 'Number and percentage of 1L IO-refractory patients with BRAF+ MM per location of metastatic site', 'timeFrame': 'Baseline'}, {'measure': 'Alanine aminotransferase (ALT) levels in 1L IO-refractory patients with BRAF+ MM', 'timeFrame': 'Baseline'}, {'measure': 'Aspartate aminotransferase (AST) levels in 1L IO-refractory patients with BRAF+ MM', 'timeFrame': 'Baseline'}, {'measure': 'Lactate dehydrogenase (LDH) levels in 1L IO-refractory patients with BRAF+ MM', 'timeFrame': 'Baseline'}, {'measure': 'Time from the first disease progression until next disease progression in 1L IO-refractory patients with BRAF+ MM', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Number and proportion of patients remaining on 1L IO therapy following disease progression', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Time patients remained on 1L IO therapy following disease progression', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Number and percentage of patients treated with 2L therapy, overall and by therapy type', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Time from the start of 1L IO until the start of 2L therapy', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Time from the first disease progression until the start of 2L therapy', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'rwPFS for 1L IO-refractory patients with BRAF+ MM', 'timeFrame': 'Up to approximately 2 years', 'description': 'rwPFS was defined as the time from the first disease progression until next progression or death from any cause.'}, {'measure': 'OS for 1L IO-refractory patients with BRAF+ MM', 'timeFrame': 'Up to approximately 2 years', 'description': 'OS was defined as the time from the first disease progression until death from any cause.'}]}, 'conditionsModule': {'conditions': ['BRAF-positive Metastatic Melanoma']}, 'descriptionModule': {'briefSummary': 'This was a retrospective, longitudinal, observational study conducted using the Flatiron Health electronic health record (EHR)-derived database. BRAF+ advanced or metastatic (i.e., stage III or IV) melanoma patients treated at oncology practices across the US were identified for potential inclusion. All included patients were aged ≥18 years and required to have a diagnosis of melanoma (International Classification of Diseases (ICD)-9 172.x \\& ICD-10 C43 or D03x), a pathologic unresectable stage III or IV diagnosis, subsequent first-line (1L) treatment with either immunotherapy (IO) (nivolumab, pembrolizumab, ipilimumab + nivolumab) or targeted therapy (TT) dafratenib + trametinib (dab/tram) on or after 01 January 2014, and evidence of a BRAF-positive result at any point in time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective, noninterventional cohort study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosis of melanoma (ICD-9 172x \\& ICD-10 C43 or D03x)\n* ≥2 documented clinical encounters on different days in the Flatiron network on or after 01 January 2011\n* Pathologic unresectable stage III or IV at initial diagnosis after 01 January 2011, or earlier stage disease accompanied by development of a first locoregional recurrence after 01 January 2011\n* Diagnosis of MM after 01 January 2011\n* Evidence of a BRAF-positive result at any point in time\n* Treatment with one of the following 1L therapies on or after 01 January 2014:\n\n * IO (nivolumab, pembrolizumab, or ipilimumab + nivolumab)\n * TT (dab/tram)\n* At least 18 years of age at the time of initiation of 1L therapy\n* At least 6-months of continuous follow-up from the time of initiation of 1L therapy\n\nExclusion Criteria:\n\n* Lacking relevant unstructured documents (i.e., information such as free text from a physician note or pathology report that is captured systematically during the data abstraction process) in the Flatiron Health database\n* Evidence of non-skin melanoma (ocular, subungual, mucosal, palmar, plantar)\n* Documented receipt of a clinical study drug, defined as any uncancelled order, administration, or oral episode for a clinical study drug for cancer at any time prior to or during 1L treatment\n* Presence of leptomeningeal disease (ICD-9 198.4 \\& ICD-10 C79.32 or C79.49)'}, 'identificationModule': {'nctId': 'NCT06251934', 'briefTitle': 'Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients With BRAF-Positive Metastatic Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients With BRAF-Positive Metastatic Melanoma', 'orgStudyIdInfo': {'id': 'CTMT212AUS66'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with high tumor burden (HTB)'}, {'label': 'Patients with low tumor burden (LTB)'}, {'label': 'Patients with central nervous system (CNS) metastases'}, {'label': 'Patients with without CNS metastases'}, {'label': '1L IO-refractory patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}